The present invention relates to an implantable support and, more particularly, to an annuloplasty prosthesis for supporting an annulus of a heart valve.
A heart valve, such as a mitral or tricuspid valve, may become defective or damaged, such as resulting from congenital malformation, disease or aging. When the valve becomes defective or damaged, the leaflets may not function properly. One common problem associated with a degenerating heart valve is an enlargement of the valve annulus (e.g., dilation). The annulus, for example, may enlarge or dilate to a point where the attached leaflets are unable to fully close, which may lead to regurgitation. As a result, surgical correction, either by valve repair procedures or by valve replacement, may be required.
Surgical reconstruction or repair procedures may include plication, chordal shortening, or chordal replacement. Another common repair procedure relates to remodeling of the valve annulus (e.g., annuloplasty), which may be accomplished by implantation of a prosthetic ring to help stabilize the annulus and to correct or prevent valvular insufficiency which may result from defect or dysfunction of the valve annulus. By properly sizing and implanting the annuloplasty ring, the valve annulus can be substantially restored to its normal, undilated, circumference.
Typically, annuloplasty rings are in the form of a rigid or flexible plastic material covered with a biocompatible cloth-like material, such as a Dacron(copyright) polymer fabric. The cloth-like covering, however, provides a site at which blood may clot. In addition, the covering may cause blood elements to coagulate and, in turn, cause thromboembolic events. As a result, a recipient of a conventional annuloplasty ring may require re-operation, thereby presenting undesirable risks to the patient.
The present invention provides an annuloplasty prosthesis for supporting an annulus of a heart valve. The prosthesis includes a substrate material over which a covering of a biocompatible biological tissue material, such as animal pericardium, is applied. The substrate may be formed of a generally rigid material (e.g., a plastic or metal) in which the substrate has a predetermined shape corresponding to an annulus of the heart valve. Alternatively, the substrate may be formed of flexible material (e.g., a soft cloth or natural tissue), which may be adjusted at implantation to accommodate the size and configuration of an annulus.
An aspect of the present invention provides an annuloplasty prosthesis for supporting an annulus of a heart valve. The annuloplasty prosthesis includes a tubular sheath of an animal tissue material having a lumen within the sheath. A length of a substrate is disposed within the lumen to facilitate implantation of the sheath at an annulus of a heart valve.
Another aspect of the present invention provides an annuloplasty prosthesis for supporting an annulus of a heart valve. The annuloplasty prosthesis includes a generally C-shaped substrate of a substantially resilient material having spaced apart ends. A sheath of an animal tissue material covers the C-shaped substrate and an implantation flange extends outwardly from a sidewall portion of the sheath.
Yet another aspect of the present invention provides an annuloplasty prosthesis for supporting an annulus of a heart valve. The annuloplasty prosthesis includes a substrate, which may be substantially flexible or resilient. A sheath of biocompatible animal tissue (e.g., animal pericardium) covers the substrate. A bridge of a flexible material extends between the ends of the substrate so as to form a generally D-shaped prosthesis. To provide additional stiffness to the structure a generally rigid or resilient rod may be disposed within the bridge of flexible material.
To the accomplishment of the foregoing and related ends, the invention, then, comprises the features hereinafter fully described and particularly pointed out in the claims. The following description and the annexed drawings set forth in detail certain illustrative aspects of the invention. These aspects are indicative, however, of but a few of the various ways in which the principles of the invention may be employed. Other objects, advantages and novel features of the invention will become apparent from the following detailed description of the invention when considered in conjunction with the drawings.